study of st-100 as treatment for dry eye disease

Conditions: Dry Eye Disease

Summary: the objective of this study is to compare the safety and efficacy of two different concentrations of st-100 ophthalmic solution to placebo (vehicle) for the treatment of the signs and symptoms of dry eye.

this is a phase 2, multi-center, double-masked, randomized, placebo-controlled clinical study. subjects will be randomized to one of the following treatment arms at visit 2 (day 1): * low dose st-100 ophthalmic solution: 1 drop twice daily (bid) in each eye * high dose st-100 ophthalmic solution: 1 drop bid in each eye * placebo ophthalmic solution (vehicle): 1 drop bid in each eye approximately 150 subjects will be randomly assigned to one of the three groups (1:1:1) to receive either st-100 ophthalmic solution or placebo solution as topical ophthalmic drops administered bilaterally bid for 4 weeks. subjects, sponsor, contract research organization (cro), and site personnel will be masked to treatment assignment. the clinical hypotheses for this study is that low dose and high dose st-100 ophthalmic solution twice daily (bid) is superior to its vehicle (bid) for the primary endpoints of signs and symptoms of dry eye.

Eligibility criteria:
inclusion criteria: * be at least 18 years of age; * provide written informed consent; * have a subject reported history of dry eye; * have a history of use of eye drops for dry eye symptoms; * have symptoms of dry eye as determined by ocular discomfort \& 4-symptom questionnaire; * have a schirmer's test score of ≤ 10 mm and ≥ 1 mm; * have conjunctival redness; * have corneal fluorescein staining; * have lissamine green conjunctival staining; * have signs and symptoms responses to controlled adverse environment (cae®); exclusion criteria: * have any clinically significant slit lamp findings; * be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation ; * have worn contact lenses; * have used any eye drops; * have previously had laser-assisted in situ keratomileusis (lasik) surgery * have used restasis, xiidra, or cequa ophthalmic solutions * have any planned ocular and/or lid surgeries or any ocular surgery; * have used, are using or anticipate using permanent or temporary punctal plugs during the study; * be currently taking any topical ophthalmic prescription; * be currently taking or have taken omega-3 supplements; * be unable to read an eye chart; * be a woman who is pregnant, nursing, or planning a pregnancy; * be unwilling to submit a urine pregnancy test (or early termination visit) if of childbearing potential; * be a woman of childbearing potential who is not using an acceptable means of birth control; * have a known allergy and/or sensitivity to the test article or its components; * have a condition or be in a situation that the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study; * be currently enrolled in an investigational drug or device study or have used an investigational drug or device; * be currently using any medication known to cause ocular drying that is not used on a stable dosing regimen; * have a known history of meibomian gland procedures (e.g., lipiflow, lpi, probing, etc.); * be unable or unwilling to follow instructions, including participation in all study assessments and visits.